臨床研究等提出・公開システム

A Phase 2b, Multicenter, Randomized, Open-label, Two-Arm Study to Evaluate the Clinical Efficacy and Safety of OHB-607 Compared to Standard Neonatal Care for the Prevention of Bronchopulmonary Dysplasia, the Most Common Cause of Chronic Lung Disease of Prematurity

Footprints Study

Mamiya Shinnosuke

PPD-SNBL K.K.

3-3-23 Nakanoshima, Kita-ku, Osaka

Shinnosuke.Mamiya@thermofisher.com

Mamiya Shinnosuke

PPD-SNBL K.K.

3-3-23 Nakanoshima, Kita-ku, Osaka

+81-80-2799-8574

Shinnosuke.Mamiya@thermofisher.com

Not Recruiting

Sept. 30, 2024

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

prevention purpose

1. Written informed consents and/or assents must be signed and dated by the subject's parent(s) prior to any study-related procedures. The informed consent and any assents for underageparents must be approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) (in accordance with local regulations).
2. Written informed consents and/or assents must be signed and dated by the subject's birth mother prior to providing study-related information related to birth mother medical history, pregnancy, and the birth of the subject. The informed consent and any assents for underage birth mothers must be approved by the IRB/IEC (in accordance with local regulations).
3. Subjects must be between 23 weeks +0 days and 27 weeks +6 days GA, inclusive.

1. Detectable major (or severe) congenital malformation identified before randomization.
2. Known or suspected chromosomal abnormality, genetic disorder, or syndrome, identified before randomization, according to the investigators opinion.
3. Hypoglycemia at baseline (blood glucose <45 mg/dL or 2.5 mmol/L) which persists in spite of glucose supplementation, to exclude severe congenital abnormalities of glucose metabolism.
4. Clinically significant neurological disease identified before randomization according to CUS (hemorrhages confined to the germinal matrix are allowed) and investigators opinion.
5. Any other condition or therapy that, in the investigators opinion, may pose a risk to the subject or interfere with the subjects potential compliance with this protocol or interfere with interpretation of results.
6. Current or planned participation in a clinical study of another investigational study treatment, device, or procedure (participation in non-interventional studies is permitted on a case-by-case basis).
7. The subject or subjects parent(s) is/are unable to comply with the protocol or is unlikely to be available for long-term follow-up as determined by the investigator.
8. Birth mother with active COVID-19 infection at birth or a history of severe COVID-19 infection (requiring intensive care hospitalization) during pregnancy.

Both

BPD, CLD, Intraventricular Hemorrhage, Retinopathy of Prematurity

Participants will receive continuous IV infusion of OHB-607 through from birth up to postmenstrual age (PMA) 29 weeks +6 days.

D010335, D012140, D012164, D005128, D007752, D007744, D011248, D005261, D000091642, D055397, D055370, D007235, D007232, D008171, D001997, D012178, D047928, D006470, D006133, D045505, C000604197

Reduction in the incidence of severe Bronchopulmonary Dysplasia (BPD) at 36 weeks (+- 3 days) Postmenstrual Age (PMA), or death at or before 36 weeks PMA, whichever comes first as compared to the standard neonatal care (SNC) group.

Aug. 02, 2024

No

De-identified individual participant data from this particular study will not be shared in order to minimize the risk that individual patients could be re-identified, given that there are limited numbers of study participants at each study site per year.

Finland/Germany/Ireland/Italy/Netherlands/Portugal/Spain/UK/Canada/United States